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Trial record 2 of 3 for:    microoptx | glaucoma

Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived (Early Bird)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03469297
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : June 28, 2022
Information provided by (Responsible Party):

Brief Summary:
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of 10 subjects will be enrolled at a single center. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Brown Glaucoma Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : October 8, 2021
Actual Study Completion Date : October 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Brown Glaucoma Implant Device: Brown Glaucoma Implant
The Brown Glaucoma Implant (BGI) is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.

Primary Outcome Measures :
  1. Overall Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)

  2. Adverse Event Rate [ Time Frame: 6 Months ]
    Rate of all AEs

Secondary Outcome Measures :
  1. Mean Change from Baseline in IOP [ Time Frame: 6 Months ]
  2. Alternative Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg

  3. Change in IOP-lowering Medications [ Time Frame: 6 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 22 years and older.
  2. Best corrected visual acuity of 20/400 or worse.in the study eye.
  3. Fellow eye with visually acuity of 20/200 or better and the visual field no worse than the study eye. If the study eye has no light perception, the fellow eye may have no light perception or better.
  4. Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg.
  5. Primary open-angle glaucoma (confirmed by gonioscopy).
  6. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: (1) Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; (2) Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or (3) Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
  7. Humphrey Visual Field (HVF) demonstrating visual field defects consistent with glaucomatous optic nerve damage.
  8. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 03:00 in the study eye.
  9. Adequate space in the anterior chamber of the study eye sufficient to support implant with the BGI, defined as two contiguous clock hours of scleral spur visualization via goinioscopy, without compression, in the superior 180 degrees of the anterior angle.
  10. Able and willing to comply with protocol requirements.
  11. Able to understand and sign the Informed Consent form.

Exclusion Criteria:

  1. Active Neovascular Glaucoma in the study eye.
  2. Pigmentary Glaucoma in the study eye.
  3. Pseudoexfoliative Glaucoma in the study eye.
  4. Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber.
  5. Anticipated need for ocular surgery within one year in the study eye.
  6. Requirement of a combined glaucoma procedure in the study eye.
  7. Contact lens use in the study eye.
  8. Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
  9. Other clinical conditions:

    1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8.
    2. Cancer requiring treatment during the duration of the study.
    3. Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.
  10. Participation in any other clinical trial during participation in this trial.
  11. Life expectancy <1 year.

If both eyes of a prospective trial participant are eligible, only the eye with the highest intraocular pressure will be selected for implant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469297

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United States, Minnesota
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
United States, Ohio
iWorks Laser and Vision Center
Dayton, Ohio, United States, 45405
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
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Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03469297    
Other Study ID Numbers: 4039
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases